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NCT02281500 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia
A Phase 1 study, sponsored by Grifols Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02281500 is a Phase 1 study that has completed, run by Grifols Therapeutics. The registered enrollment target is 24 participants.
The verdict
NCT02281500, a Phase 1 study, has completed, sponsored by Grifols Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
Interventions
- BIOLOGICAL Human Plasma-Derived Fibrinogen Concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-07-22 |
| Est. Completion | 2019-11-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02281500
The ClinicalTrials.gov registry entry for NCT02281500 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grifols Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Human Plasma-Derived Fibrinogen Concentrate is the first listed.
NCT02281500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02281500 about?
NCT02281500 is a clinical study titled "Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia". The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.
What is the current status of trial NCT02281500?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-07-22. Estimated completion is 2019-11-11.
What interventions are being tested in trial NCT02281500?
The interventions under investigation include: Human Plasma-Derived Fibrinogen Concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT02281500?
This trial is sponsored by Grifols Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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